Conductive Gel— 510(k) K221724

Name: FDA 510(k) clearance K221724
Creator: U.S. Food and Drug Administration
Published: 2022-09-23

Substantially Equivalent

Tone-A-Matic International, Inc.

FDA 510(k) clearance K221724 for Conductive Gel, Substantially Equivalent on 2022-09-23. Applicant: Tone-A-Matic International, Inc.. Device class: 2.

Clearance details

Applicant: Tone-A-Matic International, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2022-06-14
Decision date: 2022-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.